13 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ABBOTT HTSH EIA DIAGNOSTIC KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
Stryker MIS Attachments and Cutting Accessories
FDA 510(k)
FDA Class 2
·Neurology
BIOLOX DELTA CER OPTION HD 40MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 8, 2025
PALINDROME SAPPHIRE 23/40KT VT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·February 11, 2014
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 24, 2012
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·September 22, 2010
G7
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·December 8, 2025
G7
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 8, 2025
TAPERLOC COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·December 8, 2025
ALLIANCE X SERIES COLLARED INTEGRAL POROUS STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·June 20, 2017
G7 ACETABULAR SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·December 8, 2025
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018